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LIPITOR 10 MG TABLETS

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Lipitor® 10mg Tablets
Atorvastatin 10mg Tablets
Lipitor® 20mg Tablets
Atorvastatin 20mg Tablets
Lipitor® 40mg Tablets
Atorvastatin 40mg Tablets

0127, 0128, 0516
10.04.12[24]

(atorvastatin)
PATIENT INFORMATION LEAFLET
Your medicine is called Lipitor 10mg Tablets / Atorvastatin 10mg Tablets or
Lipitor 20mg Tablets / Atorvastatin 20mg Tablets or Lipitor 40mg Tablets /
Atorvastatin 40mg Tablets but will be referred to as Lipitor throughout the
patient information leaflet.
Lipitor is also available as the 80mg strength.
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lipitor is and what it is used for
2. Before you take Lipitor
3. How to take Lipitor
4. Possible side effects
5. How to store Lipitor
6. Further information
1. WHAT LIPITOR IS AND WHAT IT IS USED FOR
Lipitor belongs to a group of medicines known as statins, which are lipid
(fat) regulating medicines.
Lipitor is used to lower lipids known as cholesterol and triglycerides in the
blood when a low fat diet and life style changes on their own have failed. If
you are at an increased risk of heart disease, Lipitor can also be used to
reduce such risk even if your cholesterol levels are normal. You should
maintain a standard cholesterol lowering diet during treatment.
2. BEFORE YOU TAKE LIPITOR
Do not take Lipitor
- if you are hypersensitive (allergic) to Lipitor or to any similar medicines
used to lower blood lipids or to any of the other ingredients of the
medicine – see Section 6 for details.
- if you have or have ever had a disease which affects the liver
- if you have had any unexplained abnormal blood tests for liver function
- if you are a woman able to have children and not using reliable
contraception
- if you are pregnant or trying to become pregnant
- if you are breast-feeding.
Take special care with Lipitor
The following are reasons why Lipitor may not be suitable for you:
- if you have had a previous stroke with bleeding into the brain, or have
small pockets of fluid in the brain from previous strokes
- if you have kidney problems
- if you have an under-active thyroid gland (hypothyroidism)
- if you have had repeated or unexplained muscle aches or pains, a
personal history or family history of muscle problems
- if you have had previous muscular problems during treatment with other
lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines)
- if you regularly drink a large amount of alcohol
- if you have a history of liver disease
- if you are older than 70 years.
Check with your doctor or pharmacist before taking Lipitor
- if you have severe respiratory failure.
If any of these apply to you, your doctor will need to carry out a blood test
before and possibly during your Lipitor treatment to predict your risk of
muscle related side effects.
The risk of muscle related side effects e.g rhabdomyolysis is known to
increase when certain medicines are taken at the same time (see Section 2
“Taking other medicines”).
While you are on this medicine your doctor will monitor you closely if you
have Diabetes or are at risk of developing diabetes. You are likely to be at
risk of developing diabetes if you have high levels of sugars and fats in your
blood, are overweight and have high blood pressure.

Taking other medicines
There are some medicines that may change the effect of Lipitor or their
effect may be changed by Lipitor. This type of interaction could make one
or both of the medicines less effective. Alternatively it could increase the
risk or severity of side-effects, including the important muscle wasting
condition known as rhabdomyolysis described in Section 4:
- Medicines used to alter the way your immune system works, e.g.
ciclosporin
- Certain antibiotics or antifungal medicines, e.g. erythromycin,
clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole,
fluconazole, posaconazole, rifampin, fusidic acid
- Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates,
colestipol
- Some calcium channel blockers used for angina or high blood pressure,
e.g. amlodipine, diltiazem,; medicines to regulate your heart rhythm e.g.
digoxin, verapamil, amiodarone
- Medicines used in the treatment of HIV e.g. ritonavir, lopinavir,
atazanavir, indinavir, darunavir, etc.
- Other medicines known to interact with Lipitor include ezetimibe (which
lowers cholesterol), warfarin (which reduces blood clotting), oral contra
ceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for
heartburn and peptic ulcers), phenazone (a painkiller) and antacids
(indigestion products containing aluminium or magnesium)
- Medicines obtained without a prescription: St John’s Wort
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Taking Lipitor with food and drink
See Section 3 for instructions on how to take Lipitor. Please note the
following:
Grapefruit juice
Do not take more than one or two small glasses of grapefruit juice per day
because large quantities of grapefruit juice can change the effects of
Lipitor.
Alcohol
Avoid drinking too much alcohol while taking this medicine.
See Section 2 “Take special care with Lipitor” for details
Pregnancy and breast-feeding
Do not take Lipitor if you are pregnant, or if you are trying to become
pregnant.
Do not take Lipitor if you are able to become pregnant unless you use
reliable contraceptive measures.
Do not take Lipitor if you are breast-feeding.
The safety of Lipitor during pregnancy and breast-feeding has not yet been
proven. Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Normally this medicine does not affect your ability to drive or operate
machines. However, do not drive if this medicine affects your ability to
drive. Do not use any tools or machines if your ability to use them is
affected by this medicine.
Important information about some of the ingredients of Lipitor
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine
3. HOW TO TAKE LIPITOR
Before starting treatment, your doctor will place you on a low-cholesterol
diet, which you should maintain also during therapy with Lipitor.
The usual starting dose of Lipitor is 10 mg once a day in adults and children
aged 10 years or older. This may be increased if necessary by your doctor
until you are taking the amount you need. Your doctor will adapt the dose at
intervals of 4 weeks or more. The maximum dose of Lipitor is 80 mg once
daily for adults and 20 mg once daily for children.
Lipitor tablets should be swallowed whole with a drink of water, and can be
taken at any time of day, with or without food. However, try to take your
tablet at the same time every day.
Always take Lipitor exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The duration of treatment with Lipitor is determined by your doctor.
Please ask your doctor if you think that the effect of Lipitor is too strong or
too weak.
If you take more Lipitor than you should
If you accidently take too many Lipitor tablets (more than your usual daily
dose), contact your doctor or nearest hospital for advice.
If you forget to take Lipitor
If you forget to take a dose, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lipitor
If you have any further questions on the use of this medicine or wish to stop
your treatment, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lipitor can cause side effects, although not everybody
gets them.
If you experience any of the following serious side effects, stop taking
your tablets and tell your doctor immediately or go to the nearest
hospital accident and emergency department.
Rare: affects 1 to 10 users in 10,000:
- Serious allergic reaction which causes swelling of the face, tongue and
throat that can cause great difficulty in breathing.
- Serious illness with severe peeling and swelling of the skin, blistering of
the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches
especially on palms of hands or soles of feet which may blister.
- Muscle weakness, tenderness or pain and particularly, if at the same
time, you feel unwell or have a high temperature it may be caused by an
abnormal muscle breakdown which can be life-threatening and lead to
kidney problems.
Very rare: affect less than 1 user in 10,000:
- If you experience problems with unexpected or unusual bleeding or
bruising, this may be suggestive of a liver complaint. You should consult
your doctor as soon as possible.
Other possible side effects with Lipitor:
Common side effects (affects 1 to 10 users in 100) include:
- inflammation of the nasal passages, pain in the throat, nose bleed
- allergic reactions
- increases in blood sugar levels (if you have diabetes continue careful
monitoring of your blood sugar levels), increase in blood creatine kinase
- headache
- nausea, constipation, wind, indigestion, diarrhoea
- joint pain, muscle pain and back pain
- blood test results that show your liver function can become abnormal
Uncommon side effects (affects 1 to 10 users in 1000) include:
- anorexia (loss of appetite), weight gain, decreases in blood sugar levels
(if you have diabetes you should continue careful monitoring of your
blood sugar levels)
- having nightmares, insomnia
- dizziness, numbness or tingling in the fingers and toes, reductions of
sensation to pain or touch, change in sense of taste, loss of memory
- blurred vision
- ringing in the ears and/or head
- vomiting, belching, abdominal pain upper and lower, pancreatitis
(inflammation of the pancreas leading to stomach pain)
- hepatitis (liver inflammation)
- rash, skin rash and itching, hives, hair loss
- neck pain, muscle fatigue
- fatigue, feeling unwell, weakness, chest pain, swelling especially in the
ankles (oedema), raised temperature
- urine tests that are positive for white blood cells
Rare side effects (affects 1 to 10 users in 10,000) include:
- visual disturbance
- unexpected bleeding or bruising
- cholestasis (yellowing of the skin and whites of the eyes)
- tendon injury
Very rare side effects (affects less than 1 user in 10,000) include:
- an allergic reaction – symptoms may include sudden wheezing and chest
pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or
throat, difficulty breathing, collapse
- hearing loss
- gynecomastia (breast enlargement in men and women).
Possible side effects reported with some statins (medicines of the same
type):
- Sexual difficulties
- Depression
- Breathing problems including persistent cough and/or shortness of breath
or fever
Diabetes. This is more likely if you have high levels of sugars and fats in
your blood, are overweight and have high blood pressure. Your doctor will
monitor you while you are taking this medicine.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LIPITOR
Keep this medicine out of the reach and sight of children
o
Store below 25 C, in the original pack.
Do not take this medicine after the expiry date shown on the carton or blister
pack.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your doctor for safe disposal. Only keep the tablets if your doctor tells you
to.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
6. FURTHER INFORMATION
Lipitor package and contents:
Lipitor are white, round film-coated tablets:
Each tablet contains either 10mg, 20mg or 40mg of the active ingredient
atorvastatin (as the calcium trihydrate).
Your medicine also contains the inactive ingredients calcium carbonate,
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
polysorbate 80, hydroxypropyl cellulose, magnesium stearate,
hypromellose, macrogol 8000, titanium dioxide (E171), talc, simethicone,
stearate emulsifiers, thickening agent, benzoic acid and sorbic acid
10 mg - coded ‘ATV’ on one side and ‘10’ on the reverse side and are
available in blister packs of 28, 30 and 90 tablets
20 mg - coded ‘ATV’ on one side and ‘20’ on the reverse side and are
available in blister packs of 28, 30 and 90 tablets
40 mg - coded ‘ATV’ on one side and ‘40’ on the reverse side and are
available in blister packs of 28, 30 and 90 tablets
Manufacturer and Product Licence Holder:
Manufactured by Goedecke AG, Mooswaldallee 1, D-79090 Freiburg,
Germany and procured from within the EU. Repackaged by the Product
Licence holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlesex
HA3 0HD.
10mg Tablets - PL 15361/0127
20mg Tablets - PL 15361/0516
POM
40mg Tablets - PL 15361/0128

Leaflet revision and issue date (Ref) 10.04.12[24]
Lipitor is a registered trademark of Pfizer.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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